Intrarosa(prasterone)
Intrarosa (prasterone) is a small molecule pharmaceutical. Prasterone was first approved as Intrarosa on 2016-11-16. It is used to treat adrenal insufficiency, dyspareunia, lupus vulgaris, and sexual and gender disorders in the USA. It has been approved in Europe to treat postmenopause.
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Commercial
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Intrarosa
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Prasterone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| INTRAROSA | Millicent Pharma | N-208470 RX | 2016-11-16 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ibuprofen | ANDA | 2014-04-08 |
| prastera | unapproved drug other | 2014-02-25 |
| prastera - ibuprofen | ANDA | 2014-05-07 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| adrenal insufficiency | — | D000309 | — |
| dyspareunia | HP_0030016 | D004414 | N94.1 |
| lupus vulgaris | EFO_1001023 | D008177 | A18.4 |
| sexual and gender disorders | — | D019968 | — |
Agency Specific
FDA
EMA
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A14: Anabolic agents for systemic use
— A14A: Anabolic steroids
— A14AA: Androstan derivatives
— A14AA07: Prasterone
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03E: Androgens and female sex hormones in combination
— G03EA: Androgens and estrogens
— G03EA03: Prasterone and estrogen
— G03X: Other sex hormones and modulators of the genital system in atc
— G03XX: Other sex hormones and modulators of the genital system in atc
— G03XX01: Prasterone
HCPCS
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Clinical
Clinical Trials
186 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infertility | D007246 | HP_0000789 | — | 2 | 3 | 7 | 3 | 4 | 16 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 3 | 3 | 2 | 3 | 12 |
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | — | 2 | — | 1 | — | 3 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | 1 | 1 | — | 1 | — | 3 |
| Dyspareunia | D004414 | HP_0030016 | N94.1 | — | — | 1 | 1 | — | 2 |
| Osteoporosis | D010024 | HP_0000939 | M81.0 | — | — | — | 1 | 1 | 2 |
| Contraception behavior | D003268 | — | — | — | — | — | 1 | — | 1 |
| Frailty | D000073496 | — | R53.1 | — | — | — | 1 | — | 1 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | — | — | 1 | — | 1 |
| Penile induration | D010411 | — | N48.6 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Systemic lupus erythematosus | D008180 | HP_0002725 | M32 | — | 4 | 5 | — | — | 7 |
| Primary ovarian insufficiency | D016649 | EFO_0004266 | E28.3 | 3 | 4 | 2 | — | — | 5 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | 1 | — | 4 | 5 |
| Psychological sexual dysfunctions | D020018 | — | F52.0 | — | — | 2 | — | 2 | 4 |
| Adrenal insufficiency | D000309 | — | — | — | — | 1 | — | 3 | 4 |
| Female infertility | D007247 | EFO_0008560 | N97 | 1 | 1 | 1 | — | 1 | 3 |
| Menopause | D008593 | EFO_0003922 | N95 | — | — | 2 | — | 1 | 3 |
| Hot flashes | D019584 | — | — | — | 1 | 2 | — | — | 2 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | 1 | 1 | — | — | 2 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | 1 | 1 | — | — | 2 |
Show 13 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 2 | 1 | — | — | 1 | 3 |
| Astrocytoma | D001254 | EFO_0000271 | — | — | 2 | — | — | — | 2 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 2 | — | — | — | 2 |
| Glioblastoma | D005909 | EFO_0000515 | — | — | 2 | — | — | — | 2 |
| Multiple myeloma | D009101 | — | C90.0 | — | 1 | — | — | — | 1 |
| Immunosenescence | D000068884 | — | — | — | 1 | — | — | — | 1 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | 1 | — | — | — | 1 |
| Male breast neoplasms | D018567 | — | — | — | 1 | — | — | — | 1 |
| Pulmonary arterial hypertension | D000081029 | — | — | — | 1 | — | — | — | 1 |
| Substance withdrawal syndrome | D013375 | EFO_0005800 | — | — | 1 | — | — | — | 1 |
Show 31 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 2 | — | — | — | 1 | 3 |
| Menstruation disturbances | D008599 | HP_0400007 | N91.5 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Metabolic side effects of drugs and substances | D065606 | — | — | 1 | — | — | — | — | 1 |
| Synovial sarcoma | D013584 | — | — | 1 | — | — | — | — | 1 |
| Rectovaginal fistula | D012006 | — | N82.3 | 1 | — | — | — | — | 1 |
| Shoulder impingement syndrome | D019534 | EFO_1001178 | M75.4 | 1 | — | — | — | — | 1 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 1 | — | — | — | — | 1 |
| Shoulder pain | D020069 | HP_0030834 | M25.51 | 1 | — | — | — | — | 1 |
| Rotator cuff injuries | D000070636 | — | M75.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | — | — | 7 | 7 |
| Insulin resistance | D007333 | HP_0000855 | E88.819 | — | — | — | — | 4 | 4 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | — | — | 3 | 3 |
| Hyperandrogenism | D017588 | — | — | — | — | — | — | 3 | 3 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | — | — | — | 2 | 2 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 2 | 2 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | — | — | 2 | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 2 | 2 |
| Dental caries | D003731 | EFO_0003819 | K02 | — | — | — | — | 1 | 1 |
| Central nervous system neoplasms | D016543 | — | — | — | — | — | — | 1 | 1 |
Show 51 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Prasterone |
| INN | prasterone |
| Description | Dehydroepiandrosterone is an androstanoid that is androst-5-ene substituted by a beta-hydroxy group at position 3 and an oxo group at position 17. It is a naturally occurring steroid hormone produced by the adrenal glands. It has a role as an androgen, a human metabolite and a mouse metabolite. It is a 17-oxo steroid, an androstanoid and a 3beta-hydroxy-Delta(5)-steroid. |
| Classification | Small molecule |
| Drug class | steroids (androgens, anabolics); antiandrogens |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@]12CC[C@H]3[C@@H](CC=C4C[C@@H](O)CC[C@@]43C)[C@@H]1CCC2=O |
Identifiers
| PDB | — |
| CAS-ID | 53-43-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL90593 |
| ChEBI ID | 28689 |
| PubChem CID | 5881 |
| DrugBank | DB01708 |
| UNII ID | 459AG36T1B (ChemIDplus, GSRS) |
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Intrarosa – AMAG Pharmaceuticals
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Safety
Black-box Warning
Black-box warning for: Ibuprofen, Prastera, Prastera - ibuprofen
Adverse Events
Top Adverse Reactions
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1,158 adverse events reported
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